US FDA publishes draft guidance on nanotechnology

Published: 10-Jun-2011

First step towards providing regulatory clarity on FDA’s approach to the subject


The US Food and Drug Administration (FDA) has published a draft guidance on its current thinking on whether regulated products contain nanomaterials or involve the application of nanotechnology.

Nanotechnology is an emerging technology with a broad range of potential applications, such as increasing bioavailability of a drug, improving food packaging and in cosmetics.

The draft guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, is intended for manufacturers, suppliers, importers and other stakeholders. It is available online and open for public comment and represents the first step toward providing regulatory clarity on the FDA's approach to nanotechnology.

The FDA has not so far established any regulatory definitions of ‘nanotechnology’, ‘nanoscale’ or related terms, but acknowledges that the application of nanotechnology may result in product attributes that differ from those of conventionally manufactured products, and thus may merit examination.

Specifically the FDA has named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

‘With this guidance, we are not announcing a regulatory definition of nanotechnology,’ said Margaret Hamburg, Commissioner of Food and Drugs at the FDA. ‘However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.’

For products subject to premarket review, the FDA intends to apply the points contained in the draft guidance, when finalised, to enable it to understand better the properties and behaviour of engineered nanomaterials. For products not subject to premarket review, the FDA will urge manufacturers to consult with it early in the product development process so that questions related to the regulatory status, safety, effectiveness or public health impact of these products can be adequately addressed.

Comments and suggestions regarding the draft guidance should be submitted within 60 days.

The FDA is releasing its document in coordination with the Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials issued jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.

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